Quality Assurance Auditor 3
- USA Only
Quality Assurance Auditor 3
Job Locations: (All) | US-Remote
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Perform quality and auditing activities to assess compliance with corporate policies, industry standards, and applicable regulations. This includes conducting a variety of audit activities which may include, but not be limited to. internal process audits, pharmacovigilance audits, study specific audits (e.g. investigator site, in process, pharmacy/distribution, trial master file), and audits of vendors used to support ICON services. Provide GCP consultation to the ICON organization
Level 3 auditor independently conducts the following activities as assigned by Quality & Compliance (Q&C) management:
Performs contracted, routine and complex audits according to client expectations and/or ICON SOPs. Often assigned to act as Audit Lead for a team of auditors and/or to conduct complex audits independently
- Plans and ensures audits are scheduled.
- Conducts audits to assess adherence to protocols, SOPs, regulations, GCP, and expectations for data accuracy and completeness.
- Reports observations/findings according to client or ICON SOPs and report templates within defined timelines.
- Tracks, collects and issues responses and corrective actions according to client or ICON SOPs.
- Documents closure of audit
Interprets regulations and guidance documents governing GCP and provides the interpretation to ICON staff and clients.
- Facilitates client audits and regulatory inspections of ICON.
- Participates in Q&C projects such as management of issue escalations, CAPA projects, or other Q&C initiatives.
- Read, write and speak fluent English.
- 5+ years experience working in a clinical, regulatory, pharmacovigilance, or quality environment within CRO/ pharmaceutical / healthcare industry.
- Excellent verbal and written communication skills and interpersonal skills.
- Excellent organizational skills.
- Must possess a technical knowledge that is applicable to clinical drug development.
- An undergraduate degree, its international equivalent in the sciences, technology, auditing, etc. from an accredited institution or sufficient previous experience in auditing is required
- Extensive experience in investigator site, vendor, and process audits.
- To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.